Simplified blood sampling device and method

ABSTRACT

An apparatus and method for collecting a predetermined amount of blood or other fluid using an automated sampling system is provided.

CROSS-REFERENCE TO RELATED APPLICATIONS

This Application claims priority to U.S. Provisional Patent ApplicationSer. No. 61/976,079, filed Apr. 7, 2014, the disclosure of which ishereby incorporated by reference in its entirety.

FIELD OF THE DISCLOSURE

The disclosure relates to a method for use in treating patients andperforming biomedical research, and in particular to a method forautomatically collecting a predetermined amount of blood or other fluidfrom patients for diagnostic or research purposes.

BACKGROUND AND SUMMARY OF THE DISCLOSURE

Automated blood sampling (“ABS”) is a method of automatically collectingserial blood or other fluid samples from a patient for diagnostic orresearch purposes. ABS reduces the trauma associated with multiple“sticks” (insertion of a needle into a vein or artery) during therepeated blood sampling that is necessary to monitor disposition of drugtreatments. This may have particular relevance in sampling blood orother fluids from very young infants, such as those in neonatal orpediatric intensive care, who may have little blood to spare.

ABS has benefits in research, such as during Phase 1 and Phase 2Clinical Trials (in association with electrocardiography, blood pressurerecording, and body temperature monitoring). Automating the process ofblood or fluid sampling potentially allows sampling to be done withgreater volume and temporal accuracy (i.e. the collection of particularsample volumes at specific times), allows for the use of less humanpersonnel, and reduces the amount of fluid wasted compared to manualmethods of acquiring the same samples and data. Automated blood samplingmay also reduce the risk of infections, including nosocotnialinfections. Automated blood sampling also eliminates labor for manualassurance of catheter patency.

ABS units may also be provided in a portable embodiment. In someembodiments, the ABS unit includes a battery or other portable powersource. The use of a portable ABS allows for greater mobility of thepatient during sample collection. Patients may be able to go about dailyactivities, such as eating meals, sending mails, reading a book, andwalking to a restroom, while attached to an ABS unit. Greater mobilityand fewer sticks may lead to reduced stress. Stress involves the releaseof various hormones, and such hormones may affect the samples beingcollected in both human and non-human studies. U.S. Pat. No. 8,052,617,directed to a PORTABLE SAMPLING OR TESTING DEVICE AND METHOD FORPHARMACOKINETICS AND PHYSIOLOGY STUDIES, and U.S. patent applicationSer. No., 13/431, 377, published as U.S. Patent Application Publication2013/0261499, directed to a CARTRIDGE FOR AUTOMATED BLOOD SAMPLINGSYSTEM, disclose apparatus and methods for conducting automated bloodsampling, the teachings of each are herein incorporated by reference intheir entireties.

Biomedical research techniques, such as infusion, in vivo microdialysis,in vivo ultrafiltration, in vivo electrochemistry, and electrocardiologystudy the performance of living organs, such as the brain, heart,circulatory system, muscles, etc. These techniques also requireconnections between one or more external devices and one or more sensorsor implants in the body. Examples of devices include syringe pumps,fraction collectors, electrometers, vacuum sources, light sources, andpotentiostats. Examples of implants include infusion cannulae,ultrafiltration probes, microdialysis probes, electrodes, andbiosensors.

In typical fluid collection systems, an operator must make multipleselections from a menu to set-up and begin the testing protocol. Incomplex and sometimes chaotic medical care environments, such asintensive care units, critical care units, neonatal intensive careunits, and emergency department rooms, the use of simple, repeatableprocedures is desired to reduce the occurrence of errors. In addition,typical blood sampling procedures require time for a health careprovider to set up any test and/or manually withdraw samples fortesting. Improvements in the foregoing are desired.

The present disclosure provides an apparatus and method for collecting afluid sample from a subject for a test. In one exemplary embodiment, thetest subject is an adult human. In another exemplary embodiment, thesubject is a human child. As used herein, “test” may comprise collectionof a fluid sample, as in automated blood sampling, sampling of anotherbody fluid, or parallel acquisition of an electronic signal, such asduring blood pressure or electrocardiogram monitoring. The fluid samplecollected may be used in medical or clinical analysis of the patient fordiagnostic or research purposes. In one embodiment, the samplecollection and analysis are provided as a part of neonatal, pediatric oradult intensive care of the patient, including but not limited tomilitary intensive care. In another embodiment, the sample collectionand analysis are provided as a part of a personalized medicine regime ortreatment. Example of personalized medicine treatment include, but arenot limited to, measuring the circulating concentration of anadministered drug or tracking the patient's chemical response to a drug.In still another embodiment, the sample collection and analysis areprovided as a component of biomedical research. Those of skill in theart will recognize that the sample collection and analysis may also beprovided as part of other medical or clinical processes.

In an exemplary embodiment, the disclosure provides a method forconducting an automated fluid collection. The method comprises:connecting the test subject to the automated fluid sampling device. Thefluid sampling device includes: a pump being moveable in a firstdirection to draw fluid into the pump and a second direction to expelfluid from the pump; a reservoir in fluid communication with the pump,the reservoir having a first opening and a second opening; a firstconduit fluidly connecting the reservoir to a first fluid fittingconfigured to fluidly connect the cartridge to tubing having a distalend inserted into the subject; a second conduit fluidly connecting thereservoir to a second fluid fitting configured to connect the cartridgeto a sample collection component; and a third conduit fluidly connectingthe reservoir to a third fluid fitting configured to connect thecartridge to a sterile fluid supply. The pump is configured to move inthe first direction and second direction in response to movement of aportion of the fluid sampling device and the fluid conduits areconfigured such that a first valve of the fluid sampling device controlsfluid flow in the first fluid conduit, a second valve of the fluidsampling device controls fluid flow in the second fluid conduit, and athird valve of the fluid sampling device controls fluid flow in thethird fluid conduit, each valve having an open state and a closed state;and wherein the fluid sampling device includes a controller forcontrolling the pump and valve.

The method further comprises activating a predetermined routine on theautomated fluid sampling device, said predetermined routine includingthe steps of: opening the first valve, and moving the pump in the firstdirection to draw sample fluid through the first conduit and into thereservoir; thereby forming a sample fluid/sterile fluid interface;opening the second valve, and moving the pump in the second direction toforce a sample fluid from the reservoir through the second conduit tothe sample collection component, the sample collection componentcollecting a predetermined amount of fluid; re-opening the first valve,and moving the pump in the second direction to force the sterile fluidout of the first fluid fitting, thereby flushing the first conduit;re-opening the second valve, and moving the pump in the second directionto force the sterile fluid out of the second fluid fitting, therebyflushing the second conduit and the sample collection component, andopening the third valve, and moving the pump in the first direction todraw the sterile fluid through the third fluid fitting and into the pumpthrough the first opening of the third conduit. The activating step isperformed by depressing a single button on the automated fluid samplingdevice.

In an exemplary embodiment, the disclosure provides an apparatus forconducting an automated fluid collection. The apparatus includes: a pumpbeing moveable in a first direction to draw fluid into the pump and asecond direction to expel fluid from the pump; a reservoir in fluidcommunication with the pump, the reservoir having a first opening and asecond opening; a first conduit fluidly connecting the reservoir to afirst fluid fitting configured to fluidly connect the cartridge totubing having a distal end inserted into the subject; a second conduitfluidly connecting the reservoir to a second fluid fitting configured toconnect the cartridge to a sample collection component; and a thirdconduit fluidly connecting the reservoir to a third fluid fittingconfigured to connect the cartridge to a sterile fluid supply. The pumpis configured to move in the first direction and second direction inresponse to movement of a portion of the fluid sampling device and thefluid conduits are configured such that a first valve of the fluidsampling device controls fluid flow in the first fluid conduit, a secondvalve of the fluid sampling device controls fluid flow in the secondfluid conduit, and a third valve of the fluid sampling device controlsfluid flow in the third fluid conduit, each valve having an open stateand a closed state; and wherein the fluid sampling device includes acontroller for controlling the pump and valve.

The automated fluid sampling device further includes a user interfacecomprising a single button. Upon activation of the button, apredetermined routine is activated including the steps of: opening thefirst valve, and moving the pump in the first direction to draw samplefluid through the first conduit and into the reservoir; thereby forminga sample fluid/sterile fluid interface; opening the second valve, andmoving the pump in the second direction to force a sample fluid from thereservoir through the second conduit to the sample collection component,the sample collection component collecting a predetermined amount offluid; reopening the first valve, and moving the pump in the seconddirection to force the sterile fluid out of the first fluid fitting,thereby flushing the first conduit; re-opening the second valve, andmoving the pump in the second direction to force the sterile fluid outof the second fluid fitting, thereby flushing the second conduit and thesample collection component, and opening the third valve, and moving thepump in the first direction to draw the sterile fluid through the thirdfluid fitting and into the pump through the first opening of the thirdconduit. In a more particular embodiment, the automated fluid samplingdevice further includes a cover covering at least a portion of the userinterface. In an even more particular embodiment, at least a portion ofthe cover covers the single button.

In an exemplary embodiment, the disclosure provides a method forconducting an automated fluid collection into multiple vials. The methodcomprises (a) providing an automated fluid sampling device, theautomated fluid sampling device comprising: a pump being moveable in afirst direction to draw fluid into the pump and a second direction toexpel fluid from the pump; a reservoir in fluid communication with thepump, the reservoir having a first opening and a second opening; a firstconduit fluidly connecting the reservoir to a first fluid fittingconfigured to fluidly connect the cartridge to tubing having a distalend inserted into the subject; a second conduit fluidly connecting thereservoir to a second fluid fitting configured to connect the cartridgeto a sample collection component containing first and second samplecollection vessels; and a third conduit fluidly connecting the reservoirto a third fluid fitting configured to connect the cartridge to asterile fluid supply, wherein the pump is configured to move in thefirst direction and second direction in response to movement of aportion of the fluid sampling device when the cartridge is operablyconnected to the fluid sample device and the fluid conduits areconfigured such that when the cartridge is operably connected to thefluid sampling device, a first valve of the fluid sampling devicecontrols fluid flow in the first fluid conduit, a second valve of thefluid sampling device controls fluid flow in the second fluid conduit,and a third valve of the fluid sampling device controls fluid flow inthe third fluid conduit, each valve having an open state and a closedstate; and wherein the fluid sampling device includes a controller forcontrolling the pump and valve.

The method further comprises (b) connecting the distal end of the tubingto the subject; (c) opening the first valve, and moving the pump in thefirst direction to draw sample fluid through the first conduit and intothe reservoir; thereby forming a sample fluid/sterile fluid interface;and (d) opening the second valve, and moving the pump in the seconddirection to force sample fluid from the reservoir through the secondconduit to the first sample vessel positioned in the sample collectioncomponent. The method further comprises (e) moving the pump in thesecond direction to force sample fluid from the reservoir through thesecond conduit to the second sample vessel positioned in the samplecollection component. The method further comprises (f) re-opening thefirst valve, and moving the pump in the second direction to force thesterile fluid out of the first fluid fitting, thereby flushing the firstconduit; (g) re-opening the second valve, and moving the pump in thesecond direction to force the sterile fluid out of the second fluidfitting, thereby flushing the second conduit and the sample collectioncomponent, and (h) opening the third valve, and moving the pump in thefirst direction to draw the sterile fluid through the third fluidfitting and into the pump through the first opening of the thirdconduit, wherein steps (c)-(h) are executed by the controller.

In a more particular embodiment, the controller repeats steps (c)-(h) aplurality of times in succession. In another more particular embodiment,the method further comprises prior to step (c): actuating the pump tofill the pump with the sterile fluid; opening second valve, andactuating the pump to fill the reservoir and the second conduit with thesterile fluid; opening the first valve and actuating the pump to fillthe first conduit with the sterile fluid; coupling the tubing to thefirst fluid fitting; opening the first valve, and actuating the pump todraw a first amount of fluid from the tubing; and opening the firstvalve, and actuating the pump to return the first amount of bloodthrough the tubing to the subject. In still another more particularembodiment, the first and second sample collection vessels are differentsizes.

In an exemplary embodiment, the disclosure provides an apparatus forconducting an automated fluid collection into multiple vials. In a moreparticular embodiment, the first and second sample collection vesselsare different sizes.

The above mentioned and other features of the invention, and the mannerof attaining them, will become more apparent and the invention itselfwill be better understood by reference to the following description ofembodiments of the invention taken in conjunction with the accompanyingdrawings.

BRIEF DESCRIPTION OF THE DRAWINGS

The disclosure is explained in greater detail below in reference to thefigures. In the figures:

FIG. 1 shows an illustrative ABS cartridge attached to a portion of anABS apparatus;

FIGS. 2A-2C show an exploded view of the ABS cartridge and ABS apparatusportion of FIG. 1;

FIG. 3 illustrates an exemplary controller of the ABS apparatus of FIG.1.

FIGS. 4A-4C show several views of an illustrative ABS apparatus with anABS cartridge installed;

FIG. 5 illustrates an exemplary processing sequence for preparing an ABSapparatus and ABS cartridge for sampling;

FIG. 6 illustrates an exemplary processing sequence for taking samplesusing an ABS apparatus and ABS cartridge;

FIG. 7 illustrates an exemplary ABS apparatus for collecting multiplesamples from a single fluid draw;

FIG. 8 illustrates an exemplary processing sequence for preparing theABS apparatus of FIG. 7 for sampling;

FIG. 9A illustrates an exemplary processing sequence for taking samplesusing the ABS apparatus of FIG. 7;

FIG. 9B illustrates another exemplary processing sequence for takingsamples using the ABS apparatus of FIG. 7;

FIG. 10 shows an illustrative ABS apparatus attached to a neonateisolette;

FIGS. 11A and 11B shows an illustrative ABS apparatus attached to apatient in a health-care setting;

FIG. 12 illustrates another exemplary ABS apparatus for collectingmultiple samples from a single fluid draw;

FIG. 13 illustrates an exemplary processing sequence for preparing theABS apparatus of FIG. 12 for sampling; and

FIG. 14 illustrates an exemplary processing sequence for taking samplesusing the ABS apparatus of FIG. 12.

DETAILED DESCRIPTION OF THE DRAWINGS

The embodiments disclosed below are not intended to be exhaustive or tolimit the invention to the precise forms disclosed in the followingdetailed description. Rather, the embodiments are chosen and describedso that others skilled in the art may utilize their teachings. While thepresent disclosure is primarily directed to a sample or testing devicefor intensive care medicine, pharmacokinetics and physiology studies, itshould be understood that the features disclosed herein may haveapplication to collection of other types of samples.

Referring to FIG. 1, an illustrative ABS cartridge 10 is shown attachedto a portion of an ABS apparatus 12. In one exemplary embodiment,cartridge 10 is attached to

ABS apparatus 12 using hooks 14 and latch 16. In the illustratedembodiment, cartridge 10 is inserted into hooks 14, latch 16 isdepressed, cartridge 10 is pushed in toward ABS apparatus 12 and latch16 snaps into position. In another embodiment, cartridge 10 is attachedto ABS apparatus 12 using a plurality of hooks 14. In still anotherembodiment, cartridge 10 is attached to ABS apparatus 12 using aplurality of latches 16. Other suitable methods of removably attachingcartridge 10 to ABS apparatus 12, including but not limited to grooves,snaps, and rotatable clasps may also be used.

Cartridge 10 includes a plurality of connectors. In the exemplaryembodiment illustrated in FIG. 1, first connector 18 connects cartridge10 to a catheter conduit, which has a distal end inserted into the testsubject from which the sample is to be collected. Although the testsubject from whom the sample is to be collected in one exemplaryembodiment is a human, in other embodiments fluid samples may be takenfrom other animals. Second connector 20 connects cartridge 10 to asample collection container or fraction collector for collecting andstoring samples. Third connector 22 connects cartridge 10 to a salinebag or other physiologically compatible solution, such as, but notlimited to Ringer's solution. In another exemplary embodiment, syringeconnector 24 connects cartridge 10 to syringe pump 26. In still anotherexemplary embodiment, syringe pump 26 is provided as part of cartridge10. As illustrated, connectors 18, 20, 22, 24 are fluid fittings. In oneexemplary embodiment, connectors 18, 20, 22, 24 are leak-freeconnections such as Luer lock style connectors. Exemplary Luer lockconnectors are Luer-Lok™connectors available from Becton Dickinson &Co., Franklin Lakes, N.J. Other suitable fluid fittings may also beused.

In the exemplary embodiment illustrated in FIG. 1, syringe pump 26 isprovided as part of cartridge 10. Syringe pump 26 includes barrel 28 andplunger 30. ABS apparatus 12 includes syringe mechanism 32. Syringemechanism connector 34 connects syringe mechanism 32 to plunger 30 suchthat movement of syringe mechanism 32 moves plunger 30. In the exemplaryembodiment illustrated in FIG. 1, connector 34 attaches above and belowone end of plunger 30. Other connections are also contemplated. Forexample, plunger 30 may include a groove into which connector 34 isinserted, or a portion of plunger 30 and connector 34 may comprise a keyand slot that allow plunger 30 to move in response to movement fromsyringe mechanism 32. In one exemplary embodiment, syringe pump 26 maycomprise the Culex ABS syringe drive manufactured by BioanalyticalSystems, inc. of West Lafayette, Ind. In other embodiments, syringe pump26 is another means for moving fluid including, but not limited to, areciprocal piston pump, a peristaltic pump, or a vacuum or pressuresource.

In another exemplary embodiment, syringe pump 26 is not provided as partof cartridge 10, but is connected to cartridge 10 through syringeconnector 24 and to a portion of ABS apparatus 12 through syringemechanism connector 34.

Cartridge 10 includes fluid reservoir 36. In the exemplary embodimentillustrated in FIG. 1, reservoir 36 is a container into which fluid canbe received and dispensed.

In another exemplary embodiment, fluid reservoir 36 is an enlargedsection of conduit or tubing. In still another exemplary embodiment,fluid reservoir 36 is an extended length of conduit or tubing. In stillyet another exemplary embodiment, fluid reservoir is integrally formedwith cartridge 10.

A first end of reservoir 36 is fluidly connected to first intersectionor T connector 38. T connector 38 fluidly connects reservoir 36 to firstconnector 18 through catheter conduit 40 and second connector 20 throughcollector conduit 42.

A second end of reservoir 36 is fluidly connected to second intersectionor T connector 44. T connector 44 fluidly connects reservoir 36 to thirdconnector 22 through reservoir conduit 46 and syringe pump 26 throughsyringe conduit 48.

Although the exemplary embodiment of cartridge 10 illustrated in FIG. 1shows reservoir 36 as a vertically oriented container attached to firstT connector 38 below reservoir 36 and attached to second T connector 44above reservoir 36, other orientations are also contemplated, includingbut not limited to horizontal connections of first and second Tconnectors 38, 44 with reservoir 36 and reversing the positions of firstand second T connectors 38, 44.

In the exemplary embodiment illustrated in FIG. 1, catheter conduit 40is routed through first valve 50, collector conduit 42 is routed throughsecond valve 52, and reservoir conduit 46 is routed through third valve54. In one embodiment, valves 50, 52, 54 are operably connected to ABSapparatus 12.

Referring next to FIG. 2, an exploded view of cartridge 10 and ABSapparatus 12 of FIG. 1 is illustrated. FIG. 2A illustrates a portion ofone exemplary embodiment of cartridge 10 including connectors 18, 20,22, 24, syringe pump 26, reservoir 36, T connectors 38, 44, and conduit40, 42, 46, 48. FIG. 2B illustrates another portion of the exemplaryembodiment of cartridge 10 including cartridge frame 56. FIG. 2Cillustrates a portion of one exemplary embodiment of ABS apparatus 12for receiving cartridge 10 including hooks 14, latch 16, syringemechanism 32, and valves 50, 52, and 54.

In the exemplary embodiment illustrated in FIGS. 1 and 2, cartridgeframe 56 includes a plurality of snap and routing supports 58. Snap androuting supports 58 support cartridge components on frame 56. Theplurality of snap and routing supports 58 may include clamps, guides,snaps, and supports. As shown in FIG. 2B, snap and routing supports 58may be formed as part of cartridge frame 56. In another embodiment, snapand routing supports 58 may be attached to cartridge frame 56. Snap androuting supports 58 may be formed from a plastic or other polymericmaterial. Those of skill in the art will recognize that other materialsmay also be used. In one embodiment, snap and routing supports 58support at least one of conduit 40, 42, 46, 48. In another embodiment,snap and routing supports 58 support at least one of T connectors 38,44. In still another embodiment, snap and routing supports 58 supportsyringe barrel 28.

Referring to FIG. 2B, in one exemplary embodiment, cartridge frame 56includes recesses 60, 62, for receiving reservoir 36 and syringe pump26. In another exemplary embodiment, at least one of recesses 60, 62 arecut-outs.

In the exemplary embodiment illustrated in FIG. 2B, cartridge frame 56includes first valve window 64 for receiving valve 50, second valvewindow 66 for receiving valve 52, and third valve window 68 forreceiving valve 54 from ABS apparatus 12. In another embodiment, morethan one valve may be positioned in a window.

In one exemplary embodiment, valves 50, 52, and 54 are pinch valves thatfit around conduits 40, 42, 46 and restrict or prevent fluid flowthrough conduits 40, 42, 46 in a closed state and allow fluid flowthrough conduits 40, 42, 46 in an open state. In one embodiment, valves50, 52, and 54 include rod-like elements that fit around conduits 40,42, 46. In the open state, the rod-like elements are positioned to allowfluid to flow through conduits 40, 42, 46. In the closed state, a forceis applied to a first of the rod-like elements causing it to move towardthe second of the rod-like elements, squeezing the conduits 40, 42, 46between the rod-like elements and restricting or preventing fluid flow.In another embodiment, force is applied to both of the rod-likeelements. Force may be applied to the rod-like elements through the useof a motor and cam, a linear actuator, a pneumatic actuator, a solenoid,or other suitable methods.

In another exemplary embodiment, valves 50, 52, 54 are telescoping stylepinch valves. Telescoping style pinch valves have an open state thatallows fluid flow through conduits 40, 42, 46 and a closed state inwhich a valve element is driven from ABS apparatus 12 into contact witha conduit 40, 42, 46 and against a corresponding stationary element ofcartridge frame 56 positioned opposite the conduit 40, 42, 46 from thedriven valve element to restrict or prevent fluid flow through theconduit 40, 42, 46.

Other suitable fluid control means can be used in place of theillustrated valves.

For example, first valve 50 and second valve 52 may be replaced by asingle three-way valve. Additionally, valves 50, 52, 54 may be in-linevalves. In another embodiment, syringe pump 26 is connected to syringeconduit 48 connects syringe pump 26 to reservoir 36 through a three wayconnector with catheter conduit 40 and collector conduit 44 in place offirst T connector 38. Other suitable valves may also be used.

In another exemplary embodiment, some elements of cartridge 10 areintegrally formed with cartridge frame 56. In one embodiment, at leastone of reservoir 36, connectors 18, 20, 22, 24, syringe barrel 28, Tconnectors 38, 44, and snap and routing supports 58 are formed as partof cartridge frame 56. In another embodiment, at least one of conduits40, 42, 46, 48 is at least partially formed as part of cartridge frame56 and valves 50, 52, 54 control flow by applying a force to a portionof conduit 40, 42, 46, 48 causing the conduit to deform and restrict orprevent fluid flow. In still another embodiment, at least one ofreservoir 36, conduit 40, 42, 46, 48, connectors 18, 20, 22, 24, syringebarrel 28, and T connectors 38, 44 are integrally formed together andsecured to frame 56 prior to cartridge 10 being operably connected toABS apparatus 12.

Referring to FIG. 2C, in one exemplary embodiment, ABS apparatus 12includes recesses 70, 72, for receiving reservoir and syringe pumprecesses 60, 72. In another exemplary embodiment, at least one ofrecesses 70, 72 directly receives reservoir 36 or syringe pump 26. Inthe embodiment illustrated in FIG. 2C, ABS apparatus 12 includescartridge recess 74 for receiving cartridge 10. Cartridge 10 is securedin recess 74 by hooks 14 and latch 16.

In one exemplary embodiment, cartridge 10 and ABS apparatus 12 cooperateto allow installation of cartridge 10 into ABS apparatus 12 in only oneorientation. In the embodiment illustrated in FIGS. 1 and 2, recesses70, 72 will receive cartridge 10 in only one orientation, and syringemechanism 32 will only receive plunger 30 in the same orientation. Othermethods of allowing installation in only one orientation are alsocontemplated. For example, in another embodiment, cartridge frame 56 andcartridge recess 74 are shaped to only allow installation of cartridge10 in one orientation. In still another embodiment, cartridge frame 56is shaped so that hooks 14 and latch 16 only engage cartridge frame 56in one orientation.

Referring next to FIG. 3, when installed in ABS apparatus 12, cartridge10 cooperates with ABS apparatus 12 to provide automated fluid sampling.ABS apparatus 12 includes controller 80, which is operatively connectedto valves 50, 52, 54, syringe mechanism 32, and sample fractioncollector 82. An exemplary controller is illustrated in FIG. 8.

Controller 80 may be a single controller or multiple controllers.Controller 80 may implement programming implemented as electricalcircuits, software being executed by a processing unit, a combinationthereof, or any other suitable configuration of software and/or softwareenabled hardware. In one embodiment controller 80 comprises a computerchip with embedded software code. In another embodiment, controller 80is operably connected with user interface 92. In one embodiment, userinterface 92 includes input member 110 and output members 112. Exemplaryinput members 110 include buttons, switches, keys, a touch display, akeyboard, a mouse, and other suitable devices for providing informationto controller 80. Exemplary output members 112 include lights, a display(such as a touch screen), printer, speaker, visual devices, audiodevices, tactile devices, and other suitable devices for presentinginformation to an operator. In one embodiment, a cover 111 is providedfor user interface 92. In another embodiment controller 80 operablytransfers information to and receives information from an externalcomputer 86.

In one exemplary embodiment, user input 110 includes a single button110A (see FIG. 4A) Activation of single button 110A may be used to startan automatic fluid collection, such as automatic fluid collectionsequence 250 (see FIG. 6). Single button 110A is activated to start anautomatic fluid collection by depressing single button 110A a singletime.

In some embodiments, use of a single button 110A to start an automaticfluid collection reduces operator errors by restricting the choice oftests or testing protocols to a single selection. By using a singlebutton 110A to start the automatic fluid collection, the operator doesnot need to be trained in how to program or set-up a new test or evenmake a selection from multiple tests, minimizing the ability of theoperator to select the wrong test. This may be of particular importancewhen selecting between testing protocols having the same or similartesting sample size, testing frequency, or sample collection types. Useof a single button 110A allows for a simpler user interface 92. In oneexemplary embodiment, user interface 92 may include only single button110A. In another exemplary embodiment, a portion of user interface 92visible to the patient from whom samples are being withdrawn includesonly the single button 110A. These and similar embodiments allow for aclean and unobtrusive user interface.

In addition, use of single button 110A to start an automatic fluidcollection reduces the amount of time necessary to set up and run eachtest for a patient by eliminating the need for an operator to workthrough one or more menus to set up the test. Rather, the test isconfigured and loaded on the machine ahead of time, such that theoperator can start the test with a single press of the single button110A.

In one exemplary embodiment, at least a portion of user interface 92 iscovered by a cover 111. In some embodiments, cover 111 is a transparentand/or flexible material that allows a user to see output members 112and interact with user input members 110, including single button 110A.In some embodiments, cover 111 is cleanable with standard cleaningsupplies, which allows for cleaning of a portion ABS apparatus 88 (seeFIGS. 4A-4C) touched by a user without damaging ABS apparatus 88. Insome embodiments, cover 111 is a removable, or disposable cover that canbe changed at regular intervals to maintain a clean and/or disinfectedsurface user to interact with ABS apparatus 88.

In another embodiment, controller 80 includes memory 114. Memory is acomputer readable medium and may be a single storage device or mayinclude multiple storage devices, located either locally with controller80 or accessible across a network. Computer-readable media may be anyavailable media that may be accessed by controller 80 and includes bothvolatile and non-volatile media. Further, computer readable-media may beone or both of removable and non-removable media. By way of example,computer-readable media may include, but is not limited to, RAM, ROM,EEPROM, flash memory or other memory technology, CD-ROM, DigitalVersatile Disk (DVD) or other optical disk storage, magnetic cassettes,magnetic tape, magnetic disk storage or other magnetic storage devices,or any other medium which may be used to store the desired informationand which may be accessed by controller 80. In one embodiment,controller 80 communicates data, status information, or a combinationthereof to a remote device for analysis. In another embodiment, memorymay further include operating system software, such as WINDOWS operatingsystem available from Microsoft Corporation of Redmond Washington.Memory further includes communications software if computer system hasaccess to a network through a network connection 116, such as a localarea network, a public switched network, a CAN network, and any type ofwired or wireless network. Any exemplary public switched network is theInternet. Exemplary communications software includes e-mail software,internet browser software. Other suitable software which permitcontroller 80 to communicate with other devices across a network may beused.

In one exemplary embodiment, controller 80 controls the status of firstvalve 50 to control flow through catheter conduit 40, controls thestatus of second valve 52 to control flow through collector conduit 42,controls the status of third valve 54 to control flow through reservoirconduit 46; controls the movement of syringe pump 26 in a firstdirection drawing fluid into barrel 28 and a second direction forcingfluid from barrel 28; and instructs a sample fraction collector 82 toeither receive fluid samples in vials 84 or to pass the fluid into adrain. In another embodiment, controller 80 is operatively connected toexternal computer 86.

Referring next to FIG. 4, several views of an illustrative ABS apparatusare provided. FIG. 4A illustrates a perspective view of the front of anABS apparatus 88. The exemplary ABS apparatus 88 in FIG. 4A includeshandle 90 with a soft touch cover, user interface 92, and hooks 94 forattaching saline bag 96 or other physiologically compatible solution.First connector 18 and third connector 22 of cartridge 10 can be seenextending out the side of ABS apparatus 88.

Sample collection area 98 is provided in the bottom of ABS apparatus 88.In one embodiment, sample collection area may be refrigerated usingPeltier cooling. In another embodiment, sample collection area 98includes instruments for analyzing collected samples, such as for pointof care testing, near patient testing, or nursing stations. Exemplaryinstruments for analyzing collected samples include the Cobas c andother point of care, bedside testing and near patient systems availablefrom Roche Diagnostics, Indianapolis, Ind., the i-STAT(R) Systemavailable from Abbott Laboratories, Abbott Park, Ill., and point of caresystems available from Siemens healthcare Diagnostics Inc., Tarrytown,N.Y.. Other suitable instruments for analyzing collected samples, suchas but not limited to mass spectrometers, may also be used. In yetanother embodiment, sample collection area stores samples in vials orcartridges for later testing and analysis. In still yet anotherembodiment, samples may be deposited on or absorbed in a matrix such ascellulose, open foam polymer, or ceramics from which the sample willlater be retrieved. In another embodiment, samples are stored as driedblood samples on Guthrie cards.

As shown in the exemplary embodiment illustrated in FIG. 4B, saline bag96 can be attached to hook 94 and fluidly connected to third connector22. In FIG. 4B, ABS apparatus 88 includes back panel 100. Back panel 100may be removed from ABS apparatus 88, cartridge 10 may be installed, andback panel 100 may be replaced with access to first connector 18 andthird connector 22 of cartridge 10 provided on the side of ABS apparatus88.

As shown in FIG. 4C, ABS apparatus 88 may be provided on wheeled stand102. In the exemplary embodiment illustrated in FIG. 4C, the samplecollection area 98 is removable from ABS apparatus 88 when ABS apparatus88 is attached to wheeled stand 102.

As shown in FIG. 4C, user interface 92 includes user input 110. Userinterface 92 is illustratively covered by cover 111.

Although the position and orientation of components of cartridge 10 andABS apparatus 12 have been illustratively described, those of skill inthe art will recognize that other suitable positions and orientationsmay be used. In some embodiments, the test subject from which the sampleis taken from may influence the design.

In one embodiment, cartridge 10 and ABS apparatus 12 may include awheeled stand to allow the test subject to remain ambulatory whiletesting. In another embodiment for testing very young infants, cartridge10 and ABS apparatus 12 have components with smaller volumes than forembodiments for testing adults. In still another exemplary embodiment,ABS apparatus 12 including a portable electric power supply isincorporated into a wheel neonatal intensive care unit (NICU) isoletteor incubator or an intensive care unit (ICU) bed to enable sampling tocontinue while a patient is moved between rooms. In yet still exemplaryembodiment, ABS apparatus 12 capable is incorporated as a part ofexercise physiology devices, including but not limited to treadmills andstationary bicycles, for stress tests such as stress electrocardiograms,and evaluation of athletes, patients, or members of the military. Inanother exemplary embodiment, ABS apparatus 12 is incorporated into amilitary long range pallet system used to air transport battlecasualties.

Other suitable designs depending on the subject to be tested may also beused, including those exemplified in U.S. Pat. No. 8,052,617.

FIG. 5 illustrates an exemplary processing sequence 200 for preparing anABS apparatus 12 and ABS cartridge 10 for sampling. Although anexemplary sequence 200 is described for the exemplary ABS cartridge 10and ABS apparatus 12 illustrated in FIG. 1, the sequence 200 may be usedwith other suitable ABS apparatus as well.

In block 202, the test parameters are configured. Exemplary parametersinclude the amount of fluid to be withdrawn, the frequency of sampling,and parameters associated with the sample collection area 98, such asassociating particular sample collection vials or tubes with particulartesting periods. Configuring the test parameters in block 202 may beperformed at the ABS apparatus 12, or the test parameters can beconfigured remotely and uploaded or otherwise provided to ABS apparatus12. The configured test parameters may be saved in memory 114 as a savedroutine 118 (FIG. 3).

In block 204, the configured test parameters are associated withactivation of user input, such as single button 110A. Associating thetest parameters in block 204 may be performed at the ABS apparatus 12,or the association can be made remotely and uploaded or otherwiseprovided to ABS apparatus 12. The association may be saved in memory 114as an instruction to start a routine, such as sequence 250 (see FIG. 4)when single button 110A is depressed or otherwise activated. In block206, single button 110A is depressed or otherwise activated.

Prior to block 208, first valve 50 and second valve 52 are closed andthird valve 54 is opened. In block 208, syringe pump 26 is moved in afirst direction to fill syringe pump 26 with sterile fluid from thesaline bag 96. Moving syringe pump 26 in a first or second direction mayinclude moving plunger 30 directly or moving syringe mechanism 32connected to plunger 30 through syringe mechanism connector 34.

Third valve 54 is then closed, and in block 210, second valve 52 isopened and pump 26 is moved in a second direction to fill reservoir 36and collector conduit 42 with sterile fluid. In block 212, second valve52 is closed. In block 214, first valve 50 is opened and pump 26 ismoved in a second direction to fill catheter conduit 40 with sterilefluid. First valve 50 is closed in block 216. ABS cartridge 10 is thenready to be connected to the test subject to be sampled, as shown inblock 218. If first connector 18 has not been connected to sampletubing, that step can be done at this point. Sample tubing is positionedto collect sample fluid from the test subject, and samples are collectedin block 220. Block 220 may include at least a portion of exemplarysequence 250 (see FIG. 4).

FIG. 6 illustrates an exemplary processing sequence 250 for takingsamples using an ABS apparatus 12 and ABS cartridge 10. Although anexemplary sequence 250 is described for the exemplary ABS cartridge 10and ABS apparatus 12 illustrated in FIG. 1, the sequence 250 may be usedwith other suitable ABS apparatus as well.

In block 252, test parameters the test parameters are configured. In oneembodiment, block 252 is similar to block 202 in sequence 200. Exemplaryparameters include the amount of fluid to be withdrawn, the frequency ofsampling, and parameters associated with the sample collection area 98,such as associating particular sample collection vials or tubes withparticular testing periods. Configuring the test parameters in block 252may be performed at the ABS apparatus 12, or the test parameters can beconfigured remotely and uploaded or otherwise provided to ABS apparatus12. The configured test parameters may be saved in memory 114 as a savedroutine 118 (FIG. 3). In block 254, the configured test parameters areassociated with activation of user input, such as single button 110A. Inone embodiment, block 254 is similar to block 204 in sequence 200.Associating the test parameters in block 204 may be performed at the ABSapparatus 12, or the association can be made remotely and uploaded orotherwise provided to ABS apparatus 12. The association may be saved inmemory 114 as an instruction to start a routine, such as sequence 250when single button 110A is depressed or otherwise activated.

In block 256, the test is activated. In one exemplary embodiment, thetest is activated by depressing or otherwise activating single button110A. In another exemplary embodiment, the test is activated remotely.In a more particular embodiment, a physician or other health careprofessional may review a current status of the patient and activate atest remotely, such as over a computer or other network, the internet, asmart phone, or other suitable mobile device. In still another exemplaryembodiment, the test is activated automatically by a remote trigger,such as by a nurse at a centralized nursing station. In a moreparticular embodiment, a nurse may remotely activate the test prior toheading to the patient's location. In yet still another exemplaryembodiment, the test is activated by a change in patient status. In amore particular embodiment, the one or more characteristics of thepatient may be monitored, such as heart rate, temperature, or bloodpressure. Suitable characteristics are typically monitored using head ofbed technology common in intensive care units, critical care units, andemergency department rooms. In an illustrative embodiment, ABS apparatus12 is operatively connected to one or more of the monitoring units, suchthat a change in one or more of the characteristics being monitoredresults in an activation of the test, and/or alerting one or more healthcare professionals as to the change in the patient's status.

In block 258, valves 54 and 52 are closed if open, and first valve 50 isopened. Pump 26 is moved in a first direction to draw sample fluid fromthe test subject being sampled through first connector 18, catheterconduit 40, first “T” connector 38, and into reservoir 36. First valve50 is closed in block 260.

In block 262, second valve 52 is opened and pump 26 is moved in a seconddirection to force sample fluid from reservoir 36 through first Tconnector 38, through collector conduit 42 and second connector 20 intosample fraction collector 82. Second valve 52 is closed in block 264.

In block 266, first valve 50 is opened and pump 26 is moved in a seconddirection to force sterile fluid out of first connector 18 and flushcatheter conduit 40. Block 266 may also return sample fluid to thesubject through the sample tubing. First valve 50 is then closed inblock 268.

In block 270, second valve 52 is opened and pump 26 is moved in a seconddirection to force sterile fluid out of the second connector 20 andflush collector conduit 42.

Second valve 52 is then closed in block 272.

In block 274, third valve 54 is opened and pump 26 is moved in a firstdirection to draw sterile fluid from saline bag 96 through thirdconnector 22 and into pump 26 through syringe conduit 48. Third valve 54may then be closed.

In block 276, ABS apparatus 12 checks to see if another sample is to betaken.

If another sample is called for, the sequence returns to block 258. Ifno other sample is called for, the sequence ends in block 276. Thedecision in block 276 may be made by controller 80, external computer86, or through user interface 92 based on the desired samplingparameters.

If, at any time in sequence 200 or sequence 250, there is insufficientfluid in syringe pump 26, pump 26 can be refilled by closing valves 50,52, opening valve 54 and moving pump 26 in a first direction to drawfluid into barrel 28. Additionally, before or after this step, secondvalve 52 may be opened and pump 26 may be moved in a second direction toexpel sample fluid from the reservoir 36, T connectors 38, 44 andconduit 42, 48. If at any time in sequence 200 or sequence 250, there istoo much fluid in pump 26, thereby preventing syringe pump 26 frommoving in a first direction because barrel 28 is already full, excessfluid can be purged by opening only second valve 52 and moving pump 26in a second direction to expel sample fluid from pump 26.

Referring next to FIG. 7, an additional ABS apparatus 120 isillustrated. ABS apparatus 120 is similar to ABS cartridge 10 and ABSapparatus 12, and ABS apparatus 88, and similar part numbers are used toillustrate similar parts. Reservoir conduit 46 of ABS apparatus 120 isfluidly connected to a solution 122, such as saline bag or otherphysiologically compatible solution, such as, but not limited toRinger's solution. ABS apparatus 120 further includes a syringe pump 26having plunger 30 operatively connected to a syringe mechanism 32.Syringe pump 26 is fluidly connected to fluid reservoir 36 by syringeconduit 48.

Fluid reservoir 36 is fluidly connected to solution 122 throughreservoir conduit 46, flow through which is controlled by third valve54. Fluid reservoir 36 is fluidly connected to a patient throughcatheter conduit 40, flow through which is controlled by first valve 50.Flow through collector conduit 42 is controlled by second valve 52. Inone embodiment, valves 50, 52, 54 are operably connected to ABSapparatus 120 and controlled by controller 80 (FIG. 3).

Samples from reservoir 36 are provided through collector conduit 42 tosample collection area 98. In the illustrated embodiment, samplecollection area 98 includes first sample vessel 124A and second samplevessel 124B. In the illustrated embodiment, first sample vessel 124A andsecond sample vessel 124B are different sizes. In other embodiments,first sample vessel 124A and second sample vessel 124B are the samesize. Although sample vessels 124 are illustrated as first sample vessel124A and 124B, in other embodiments, third, fourth, or additional samplevessels may also be included. Sample collection area 98 further includeswaste fluid vessel 126. Sample collection area 98 can move at least oneof an end 42A collector conduit 42, sample vessels 124, and waste fluidvessel 126 to selectively put reservoir 36 in fluid connection with oneof sample vessels 124, and waste fluid vessel 126. In one embodiment,sample collection are 98 may include one or more sample selection valves(not shown) to place each sample vessel 124 and waste fluid vessel 126into fluid communication with collector conduit 42.

In another embodiment, sample collection area 98 includes only a singlesample vessel 124 at a time. In this embodiment, providing only a singlesample vessel 124 reduces the necessary space and weight associated withsample collection area 98, which allows for a smaller and more compactABS apparatus 12. In exemplary embodiments in which the sample vessel124 is to be cooled after collection, such as refrigerated using Peltiercooling in sample collection area 98 as described above, providing onlya single sample vessel 124 to be cooled reduces the power requirementsof ABS apparatus 12. Following removal of the filled sample vessel 124from sample collection area 98, a replacement sample vessel 124 ispositioned in sample collection area for collection of a subsequentsample. In one embodiment, a plurality of empty sample vessels 124 arequeued as a magazine (not shown) to positioned in sample collection area98 following removal of the filled sample vessel 124. In a moreparticular embodiment, sample collection area may automatically positionthe next empty sample vessel 124 from the magazine in the samplecollection area following removal of the filled sample vessel 124.

In illustrative embodiments where ABS apparatus 12, ABS apparatus 88,and/or ABS apparatus 120 is provided as a portable embodiment, asdescribed above, the reduction in space, weight, and power requirementsallow for a more compact design. The use of a portable ABS allows forgreater mobility of the patient during sample collection. Patients maybe able to go about daily activities, such as eating meals, sendingemails, reading a book, and walking to a restroom, while attached to anABS unit. Greater mobility and fewer sticks may lead to reduced stress.

FIG. 8 illustrates an exemplary processing sequence 300 for preparing anABS apparatus 120 for sampling. Although an exemplary sequence 300 isdescribed for the exemplary ABS apparatus 120 illustrated in FIG. 7, thesequence 300 may be used with other suitable ABS apparatus as well.

In block 302, the sample collection area 98 is set up. First samplecollection vessel 124A and second sample collection vessel 124B arepositioned in the sample collection area 98, along with waste fluidvessel 126. First valve 50 and second valve 52 are closed and thirdvalve 54 is opened. In block 304, syringe pump 26 is moved in a firstdirection to fill syringe pump 26 with sterile fluid from the saline bag96. Moving syringe pump 26 in a first or second direction may includemoving plunger 30 directly or moving syringe mechanism 32 connected toplunger 30 through syringe mechanism connector 34.

Third valve 54 is then closed, and in block 306, second valve 52 isopened and pump 26 is moved in a second direction to fill reservoir 36and collector conduit 42 with sterile fluid. In block 308, second valve52 is closed. In block 310, first valve 50 is opened and pump 26 ismoved in a second direction to fill catheter conduit 40 with sterilefluid. First valve 50 is closed in block 312. ABS apparatus 120 is thenready to be connected to the test subject to be sampled, as shown inblock 314. If first connector 18 has not been connected to sampletubing, that step can be done at this point. Sample tubing is positionedto collect sample fluid from the test subject, and samples are collectedin block 316. Block 316 may include at least a portion of exemplarysequence 350 or sequence 400 (see FIGS. 9A and 9B).

FIG. 9A illustrates an exemplary processing sequence 350 for preparingan ABS apparatus 120 for sampling. Although an exemplary sequence 350 isdescribed for the exemplary ABS apparatus 120 illustrated in FIG. 7, thesequence 350 may be used with other suitable ABS apparatus as well.

In block 352, the ABS apparatus 120 is prepared for sampling. Block 352may include sequence 350 of FIG. 8. In block 354, valves 54 and 52 areclosed if open, and first valve 50 is opened. Pump 26 is moved in afirst direction to draw sample fluid from the test subject being sampledthrough first connector 18, catheter conduit 40, and into reservoir 36.

First valve 50 is closed in block 356.

In block 358, second valve 52 is opened and pump 26 is moved in a seconddirection to force sample fluid from reservoir 36 through collectorconduit 42 into first sample vessel 124A. Sample collection area 98collects a predetermined amount of a first fluid sample in first samplevessel 124A in block 360. Pump 26 then stop.

Sample collection area 98 then fluidly disconnects from the first samplevessel 124A and fluid connects to second sample vessel 124B in block362. In one exemplary embodiment, block 362 is performed by moving end42A of collector conduit 42 from a position proximal to first samplevessel 124A to a position proximal to second sample vessel 124B. Inanother exemplary embodiment, block 362 is performed by moving firstsample vessel 124A from a position proximal to an end 42A of collectorconduit 42 to another position, and moving second sample vessel 124Bfrom another position to a position proximal to the end 42A of collectorconduit. In yet another exemplary embodiment, block 362 is performed byclosing a first collector valve (not shown) controlling fluidcommunication between reservoir 36 and first sample vessel 124A andopening a second collector valve (not shown) controlling fluidcommunication between reservoir 36 and second sample vessel 124B.

In block 364, pump 26 is again moved in the second direction to forcesample fluid from reservoir 36 through collector conduit 42 into secondsample vessel 124B. Sample collection area 98 collects a predeterminedamount of a second fluid sample in second sample vessel 124B in block364. Pump 26 then stop.

In block 366, the second valve is closed. In block 368, first valve 50is opened and pump 26 is moved in a second direction to force sterilefluid out of first connector 18 and flush catheter conduit 40. Block 368may also return sample fluid to the subject through the sample tubing.First valve 50 is then closed in block 370.

In block 372, second valve 52 is opened and pump 26 is moved in a seconddirection to force sterile fluid out of the second connector 20 andflush collector conduit 42. Second valve 52 is then closed in block 374.

In block 376, third valve 54 is opened and pump 26 is moved in a firstdirection to draw sterile fluid from saline bag 96 through thirdconnector 22 and into pump 26 through syringe conduit 48. Third valve 54may then be closed.

In block 378, ABS apparatus 120 checks to see if another sample is to betaken. If another sample is called for, the sequence returns to block354. If no other sample is called for, the sequence ends in block 380.The decision in block 378 be made by controller 80, external computer86, or through user interface 92 based on the desired samplingparameters.

Sequence 350 avoids a full recycling of the device to obtain additionalsamples using different anticoagulants or different isotopically labeledinternal standards for mass spectrometry. Additional sample can bepurged from reservoir 36 and/or collector conduit 42 by fluidlyconnecting waste fluid vessel 126 to reservoir 36 and opening secondvalve 52 while moving pump 26 in the second direction.

If, at any time in sequence 300 (FIG. 8), sequence 350 (FIG. 9A),sequence 400 (FIG. 9B), there is insufficient fluid in syringe pump 26,pump 26 can be refilled by closing valves 50, 52, opening valve 54 andmoving pump 26 in a first direction to draw fluid into barrel 28.Additionally, before or after this step, second valve 52 may be openedand pump 26 may be moved in a second direction to expel sample fluidfrom the reservoir 36, T connectors 38, 44 and conduit 42, 48. If at anytime in sequence 200 or sequence 250, there is too much fluid in pump26, thereby preventing syringe pump 26 from moving in a first directionbecause barrel 28 is already full, excess fluid can be purged by openingonly second valve 52 and moving pump 26 in a second direction to expelsample fluid from pump 26.

FIG. 9B illustrates another exemplary processing sequence 400 forpreparing an ABS apparatus 120. Although an exemplary sequence 400 isdescribed for the exemplary ABS apparatus 120 illustrated in FIG. 7, thesequence 400 may be used with other suitable ABS apparatus as well.

In block 402, the ABS apparatus 120 is prepared for sampling. Block 402may include sequence 350 of FIG. 8. In block 404, valves 54 and 52 areclosed if open, and first valve 50 is opened. Pump 26 is moved in afirst direction to draw sample fluid from the test subject being sampledthrough first connector 18, catheter conduit 40, and into reservoir 36.First valve 50 is closed in block 406.

In block 408, second valve 52 is opened and pump 26 is moved in a seconddirection to force a portion of the sample fluid from reservoir 36through collector conduit 42 into waste fluid vessel 126. In step 410,movement of pump 26 is stopped, and sample collection area 98 fluidlydisconnects waste fluid vessel 126 from the reservoir 36 and fluidlyconnects reservoir 36 to first sample vessel 124A. In one exemplaryembodiment, block 410 is performed by moving end 42A of collectorconduit 42 from a position proximal to waste fluid vessel 126 to thefirst sample vessel 124A. In another exemplary embodiment, block 410 isperformed by moving waste fluid vessel 126 from a position proximal toan end 42A of collector conduit to another position, and moving firstsample vessel 124A from another position to a position proximal to end42A of collector conduit 42. In yet another exemplary embodiment, block410 is performed by closing a first collector valve (not shown)controlling fluid communication between reservoir 36 and waste fluidvessel 126 and opening a second collector valve (not shown) controllingfluid communication between reservoir 36 and first sample vessel 124A.

In block 412, movement of pump 26 is restarted in the second directionto force sample fluid from reservoir 36 through collector conduit 42into first sample vessel 124A. A predetermined amount of sample iscollected in first sample vessel 124A by moving plunger 30 of pump 26 apredetermined distance. In block 414, movement of pump 26 is stopped,and sample collection area 98 fluidly disconnects first sample vessel124A from the reservoir 36 and fluidly connects reservoir 36 to secondsample vessel 124B. In one exemplary embodiment, block 414 is performedby moving end 42A of collector conduit 42 from a position proximal tofirst sample vessel 124A to the second sample vessel 124B. In anotherexemplary embodiment, block 414 is performed by moving first samplevessel 124A from a position proximal to an end 42A of collector conduitto another position, and moving second sample vessel 124B from anotherposition to a position proximal to end 42A of collector conduit 42. Inyet another exemplary embodiment, block 414 is performed by closing asecond collector valve (not shown) controlling fluid communicationbetween reservoir 36 and first sample vessel 124A and opening a thirdcollector valve (not shown) controlling fluid communication betweenreservoir 36 and second sample vessel 124B.

In block 416, movement of pump 26 is restarted in the second directionto force sample fluid from reservoir 36 through collector conduit 42into second sample vessel 124B. A predetermined amount of sample iscollected in second sample vessel 124B by moving plunger 30 of pump 26 apredetermined distance. In block 418, second valve is then closed. Inblock 420, first valve 50 is opened and pump 26 is moved in a seconddirection to flush reservoir 36 and catheter conduit 40 with sterilefluid. Block 420 may return sample fluid to the subject through thesample tubing. First valve 50 is then closed in block 422.

In block 424, movement of pump 26 is stopped, and sample collection area98 fluidly disconnects second sample vessel 124B from the reservoir 36and fluidly connects reservoir 36 to waste fluid vessel 126. In oneexemplary embodiment, block 424 is performed by moving end 42A ofcollector conduit 42 from a position proximal to second sample vessel124B to the waste fluid vessel 126. In another exemplary embodiment,block 424 is performed by moving second sample vessel 124B from aposition proximal to an end 42A of collector conduit to anotherposition, and moving waste fluid vessel 126 from another position to aposition proximal to end 42A of collector conduit 42. In yet anotherexemplary embodiment, block 424 is performed by closing a thirdcollector valve (not shown) controlling fluid communication betweenreservoir 36 and second sample vessel 124B and opening a first collectorvalve (not shown) controlling fluid communication between reservoir 36and waste fluid vessel 126.

In block 426, second valve 52 is opened and pump 26 is moved in thesecond direction to flush collection conduit 42 with sterile fluid. Theflushed fluid is deposited in waste fluid vessel 126, where it may bedisposed of Second valve 52 is then closed in block 428.

If additional sterile fluid is needed in the system, in block 430, thirdvalve 54 is opened and pump 26 is moved in the first direction to drawsterile fluid from saline bag 96 through third connector 22 and intopump 26 through syringe conduit 48. Third valve 54 may then be closed.

In block 432, ABS apparatus 120 checks to see if another sample is to betaken. If another sample is called for, the sequence returns to block404. If no other sample is called for, the sequence ends in block 434.The decision in block 432 be made by controller 80, external computer86, or through user interface 92 based on the desired samplingparameters.

Additional sample can be purged from reservoir 36 and/or collectorconduit 42 by fluidly connecting waste fluid vessel 126 to reservoir 36and opening second valve 52 while moving pump 26 in the seconddirection.

The frequency and volumes of samples taken from the test subject dependon the needs of the test and decisions of medical personnel. In oneexemplary embodiment, samples are collected from the test subject at aregular frequency of about every 60 seconds to every several hours. Inanother exemplary embodiment, samples are collected at predeterminedtimes, a predetermined regular frequency, a variable time, or somecombination stored in memory or programmed by the controller. In yetanother exemplary embodiment, a sample will be collected upon a signalfrom ABS apparatus 12. In one exemplary embodiment, sample volumes ofabout 25 μL to about 4 mL are collected. In another exemplaryembodiment, sample volumes of about 5 μL to about 4 mL are collected. Instill another exemplary embodiment, sample volumes of less than about 5μL are collected. In yet still another exemplary embodiment, samplevolumes of about 4 mL to about 10 mL or more are collected. Otherfrequencies and volumes than those presented may also be used. In oneexemplary embodiment, a log file identifying at least one of thepatient, sample, caregiver, and time taken are recorded by ABS apparatus120 in memory 114. In another exemplary embodiment, frequency and volumeare selected from several options presented on user interface 92. Instill another exemplary embodiment, a saved routine 118 includingfrequency and volume settings stored in memory 114 is selected fromseveral options presented on user interface 92.

Referring next to FIG. 10, an exemplary ABS apparatus 128 is illustratedattached to a neonatal isolette 130. ABS apparatus 128 may be similar toABS apparatus 12, ABS apparatus 88, and/or ABS apparatus 120, andsimilar part numbers are used to illustrate similar parts.

Referring next to FIGS. 11A and 11B, another exemplary ABS apparatus 132is illustrated in a health care setting. ABS apparatus 132 may besimilar to ABS apparatus 12, ABS apparatus 88, ABS apparatus 120, and/orABS apparatus 132, and similar part numbers are used to illustratesimilar parts. ABS apparatus 132 illustratively includes a stationary orwheeled stand 102 for positioning ABS apparatus 132 near a head ofpatient bed 134. As illustrated in FIG. 11B, reservoir conduit 46 of ABSapparatus 120 is fluidly connected to a solution 122, such as salinebag. ABS apparatus 132 further includes a syringe pump 26 having plunger30 operatively connected to a syringe mechanism 32. Syringe pump 26 isfluidly connected to fluid reservoir 36 by syringe conduit 48. Fluidreservoir 36 is fluidly connected to solution 122 through reservoirconduit 46, flow through which is controlled by third valve 54. Fluidreservoir 36 is fluidly connected to a patient 136 through catheterconduit 40, flow through which is controlled by first valve 50. Flowthrough collector conduit 42 is controlled by second valve 52. In oneembodiment, valves 50, 52, 54 are operably connected to ABS apparatus120 and controlled by controller 80. Samples from reservoir 36 areprovided through collector conduit 42 to sample collection area 98. Inthe illustrated embodiment, sample collection area 98 includes a samplevessel 124 and waste fluid vessel 126.

Referring next to FIG. 12, in another embodiment, an additional ABSapparatus 150 is illustrated. ABS apparatus 150 is similar to ABScartridge 10, ABS apparatus 12, ABS apparatus 88, and ABS apparatus 120,and similar part numbers are used to illustrate similar parts. ABSapparatus 150 includes a pump 26′ having plunger 30 operativelyconnected to a mechanism 32. Pump 26′ is fluidly connected to fluidreservoir 36 by conduit 48. In one exemplary embodiment, a volume offluid reservoir 36 is relatively small compared to the amount of fluidprovided in an interior 27 of pump 26′.

In one exemplary embodiment, an interior 27 of pump 26′ is prefilledwith a sterile saline or other physiologically compatible solution, suchas, but not limited to Ringer's solution. In one exemplary embodiment,pump 26′ is a pre-filled sterile cartridge isolated from one or more ofthe remaining structure. In one exemplary embodiment, pump 26′ is asyringe pump including a plunger 30 or other external structure. Asshown in FIG. 12, pump 26′ is illustratively connected to mechanism 32.A mechanism connector 34 connects mechanism 32 to plunger 30 such thatmovement of mechanism 32 in one direction moves plunger 30 in a firstdirection, and movement of mechanism 32 is another direction movesplunger 30 in a second direction.

Fluid reservoir 36 is fluidly connected to a patient through catheterconduit 40, flow through which is controlled by first valve 50. Flowthrough collector conduit 42 is controlled by second valve 52. In oneembodiment, valves 50 and 52 are operably connected to ABS apparatus 150and controlled by controller 80 (FIG. 3). Samples from reservoir 36 areprovided through collector conduit 42 to sample collection area 98. Inone exemplary embodiments, the samples collected by ABS apparatus 150have volumes of as little as 0.01 cm³, 0.05 cm³, as great as 0.1 cm³,0.2 cm³, or within any range defined between any two of these values,such as 0.01 cm³ to 0.2 cm³ or 0.05 cm³ to 0.1 cm³.

FIG. 13 illustrates an exemplary processing sequence 450 for preparingan ABS apparatus 150 for sampling. Although an exemplary sequence 450 isdescribed for the exemplary ABS apparatus 150 illustrated in FIG. 12,the sequence 450 may be used with other suitable ABS apparatus as well.

In block 452, the test parameters are configured. Exemplary parametersinclude the amount of fluid to be withdrawn, the frequency of sampling,and parameters associated with the sample collection area 98, such asassociating particular sample collection vials or tubes with particulartesting periods. Configuring the test parameters in block 452 may beperformed at the ABS apparatus 150, or the test parameters can beconfigured remotely and uploaded or otherwise provided to ABS apparatus150. The configured test parameters may be saved in memory 114 as asaved routine 118 (FIG. 3).

In block 454, the configured test parameters are associated withactivation of a user input, such as single button 110A. Associating thetest parameters in block 454 may be performed at the ABS apparatus 150,or the association can be made remotely and uploaded or otherwiseprovided to ABS apparatus 150. The association may be saved in memory114 as an instruction to start a routine, such as routine 500 (see FIG.14) when a user input such as single button 110A is depressed orotherwise activated. In block 456, a user input such as single button110A is depressed or otherwise activated.

Prior to block 458, first valve 50 and second valve 52 are closed. Inblock 458, second valve 52 is opened and pump 26′ is moved in a seconddirection to fill reservoir 36 and collector conduit 42 with sterilefluid provided from interior 27 of pump 26′. In block 460, second valve52 is closed. In block 462, first valve 50 is opened and pump 26′ ismoved in a second direction to fill catheter conduit 40 with sterilefluid. First valve 50 is closed in block 464. ABS apparatus 150 is thenready to be connected to the test subject to be sampled, as shown inblock 468. If first connector 18 has not been connected to sampletubing, that step can be done at this point. Sample tubing is positionedto collect sample fluid from the test subject, and samples are collectedin block 470. Block 470 may include at least a portion of exemplarysequence 500 (see FIG. 14).

FIG. 14 illustrates an exemplary processing sequence 500 for preparingan ABS apparatus 150 for sampling. Although an exemplary sequence 500 isdescribed for the exemplary ABS apparatus 150 illustrated in FIG. 12,the sequence 500 may be used with other suitable ABS apparatus as well.

In block 502, the ABS apparatus 150 is prepared for sampling. Block 502may include sequence 450 of FIG. 13. In block 504, the test isactivated. In one exemplary embodiment, the test is activated bydepressing or otherwise activating a user input such as single button110A. In another exemplary embodiment, the test is activated remotely.In a more particular embodiment, a physician or other health careprofessional may review a current status of the patient and activate atest remotely, such as over a computer or other network, the internet, asmart phone, or other suitable mobile device. In still another exemplaryembodiment, the test is activated automatically by a remote trigger,such as by a nurse at a centralized nursing station. In a moreparticular embodiment, a nurse may remotely activate the test prior toheading to the patient's location. In yet still another exemplaryembodiment, the test is activated by a change in patient status. In amore particular embodiment, the one or more characteristics of thepatient may be monitored, such as heart rate, temperature, or bloodpressure.

In block 506 second valve 52 is opened and pump 26′ is moved in a seconddirection to force sample fluid from reservoir 36 through first Tconnector 38, through collector conduit 42 and second connector 20 intosample fraction collector 82. Second valve 52 is closed in block 508.

In block 510, first valve 50 is opened and pump 26′ is moved in a seconddirection to force sterile fluid out of first connector 18 and flushcatheter conduit 40. Block 510 may also return sample fluid to thesubject through the sample tubing. First valve 50 is then closed inblock 512.

In block 514, second valve 52 is opened and pump 26′ is moved in asecond direction to force sterile fluid out of the second connector 20and flush collector conduit 42.

Second valve 52 is then closed in block 516.

In block 518, ABS apparatus 150 determines if another sample is to betaken. If another sample is called for, the sequence 500 returns toblock 506. If no other sample is called for, the sequence 500 ends inblock 520. The decision in block 518 may be made by controller 80,external computer 86, or through user interface 92 based on the desiredsampling parameters.

The features of the disclosure disclosed in the above description, theclaims and the figures can be of importance individually as well as inany combination for the realization of the disclosure in its variousembodiments.

What is claimed is:
 1. A method of collecting a fluid sample from a testsubject with an automated fluid sampling device, the method comprising:connecting the test subject to the automated fluid sampling device, thefluid sampling device including: a pump being moveable in a firstdirection to draw fluid into the pump and a second direction to expelfluid from the pump; a reservoir in fluid communication with the pump,the reservoir having a first opening and a second opening; a firstconduit fluidly connecting the reservoir to a first fluid fittingconfigured to fluidly connect the reservoir to tubing having a distalend inserted into the test subject; a second conduit fluidly connectingthe reservoir to a second fluid fitting configured to connect thereservoir to a sample collection component; and a third conduit fluidlyconnecting the reservoir to a third fluid fitting configured to connectthe reservoir to a sterile fluid supply; wherein the pump is configuredto move in the first direction and second direction in response tomovement of a portion of the fluid sampling device and the conduits areconfigured such that a first valve of the fluid sampling device controlsfluid flow in the first conduit, a second valve of the fluid samplingdevice controls fluid flow in the second conduit, and a third valve ofthe fluid sampling device controls fluid flow in the third conduit, eachvalve having an open state and a closed state; and wherein the fluidsampling device includes a controller for controlling the pump andvalve; activating a predetermined routine on the automated fluidsampling device, said predetermined routine including the steps of:opening the first valve, and moving the pump in the first direction todraw sample fluid through the first conduit and into the reservoir;thereby forming a sample fluid/sterile fluid interface; opening thesecond valve, and moving the pump in the second direction to force asample fluid from the reservoir through the second conduit to the samplecollection component, the sample collection component collecting apredetermined amount of fluid; re-opening the first valve, and movingthe pump in the second direction to force the sterile fluid out of thefirst fluid fitting, thereby flushing the first conduit; re-opening thesecond valve, and moving the pump in the second direction to force thesterile fluid out of the second fluid fitting, thereby flushing thesecond conduit and the sample collection component, and opening thethird valve, and moving the pump in the first direction to draw thesterile fluid through the third fluid fitting and into the pump throughthe first opening of the third conduit; wherein said activating step isperformed by depressing a single button on the automated fluid samplingdevice.
 2. The method of claim 1, wherein the automated fluid samplingdevice further includes non-volatile memory, wherein the predeterminedroutine is saved in the non-volatile memory.
 3. The method of claim 2,wherein the predetermined routine includes the predetermined amount offluid collected in the sample collection component.
 4. The method ofclaim 3, wherein the predetermined routine is repeated.
 5. The method ofclaim 4, wherein the non-volatile memory further includes a frequencythat the predetermined routine is to be repeated.
 6. The method of claim1, wherein the automated fluid sampling device further includes a userinterface comprising the single button.
 7. The method of claim 6,wherein the automated fluid sampling device further includes a covercovering at least a portion of the user interface.
 8. The method ofclaim 7, wherein the cover covers the single button.
 9. The method ofclaim 7, wherein the cover is flexible.
 10. The method of claim 7,wherein the cover is transparent.
 11. The method of claim 1, furthercomprising closing the first valve and second valve, opening the thirdvalve, and moving the pump in the first direction to draw fluid into thepump.
 12. The method of claim 11, further comprising opening the secondvalve and moving the pump in the second direction to expel fluid fromthe reservoir.
 13. The method of claim 1, further comprising closing thefirst and third valves, opening the second valve, and moving pump in thesecond direction to expel fluid from the pump.
 14. An automated fluidsampling device comprising: a pump being moveable in a first directionto draw fluid into the pump and a second direction to expel fluid fromthe pump, an interior of the pump including a sterile fluid supply; areservoir in fluid communication with the pump, the reservoir having afirst opening and a second opening; a first conduit fluidly connectingthe reservoir to a first fluid fitting configured to fluidly connect thereservoir to tubing having a distal end inserted into a test subject;and a second conduit fluidly connecting the reservoir to a second fluidfitting configured to connect the reservoir to a sample collectioncomponent; wherein the pump is configured to move in the first directionand second direction in response to movement of a portion of the fluidsampling device and the conduits are configured such that a first valveof the fluid sampling device controls fluid flow in the first conduit,and a second valve of the fluid sampling device controls fluid flow inthe second conduit, each valve having an open state and a closed state;and wherein the fluid sampling device includes a controller forcontrolling the pump and valve.
 15. The automated fluid sampling deviceof claim 14, wherein the automated fluid sampling device furtherincludes a cover covering at least a portion of a user interface. 16.The automated fluid sampling device of claim 14, wherein the sterilefluid supply comprises a fluid selected from the group consisting ofsaline and Ringer's solution.
 17. The automated fluid sample device ofclaim 14, wherein the sample collection component includes a firstsample vessel configured to receive a sample from through the secondconduit and a waste fluid vessel.
 18. The automated fluid sample deviceof claim 14, wherein the sample collection component includes aplurality of empty sample containers queued as a magazine tosequentially receive a sample through the second conduit.
 19. A methodof collecting a fluid sample from a test subject with an automated fluidsampling device, the method comprising: connecting the test subject tothe automated fluid sampling device, the fluid sampling deviceincluding: a pump being moveable in a first direction to draw fluid intothe pump and a second direction to expel fluid from the pump, aninterior of the pump including a sterile fluid supply; a reservoir influid communication with the pump, the reservoir having a first openingand a second opening; a first conduit fluidly connecting the reservoirto a first fluid fitting configured to fluidly connect the reservoir totubing having a distal end inserted into the subject; and a secondconduit fluidly connecting the reservoir to a second fluid fittingconfigured to connect the reservoir to a sample collection component;wherein the pump is configured to move in the first direction and seconddirection in response to movement of a portion of the fluid samplingdevice and the conduits are configured such that a first valve of thefluid sampling device controls fluid flow in the first conduit, and asecond valve of the fluid sampling device controls fluid flow in thesecond conduit, each valve having an open state and a closed state; andwherein the fluid sampling device includes a controller for controllingthe pump and valve activating a predetermined routine on the automatedfluid sampling device, said predetermined routine including the stepsof: opening the first valve, and moving the pump in the first directionto draw sample fluid through the first conduit and into the reservoir;thereby forming a sample fluid/sterile fluid interface; opening thesecond valve, and moving the pump in the second direction to force asample fluid from the reservoir through the second conduit to the samplecollection component, the sample collection component collecting apredetermined amount of fluid; and re-opening the first valve, andmoving the pump in the second direction to force the sterile fluid outof the first fluid fitting, thereby flushing the first conduit;re-opening the second valve, and moving the pump in the second directionto force the sterile fluid out of the second fluid fitting, therebyflushing the second conduit and the sample collection component.
 20. Themethod of claim 19, wherein the predetermined amount of fluid collectedby the sample collection component is from 0.05 cm³ to 0.1 cm³.